Joint Global Study definition

Joint Global Study shall have the meaning set forth in Section 5.4(b).
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Joint Global Study means any Global Study that has been agreed by the Parties to be included into the Joint Global Development Plan and jointly conducted by the Parties. Each Joint Global Study objectives, designs, study execution plan shall be agreed to by the Parties and studies may be conducted in both the Retained and Licensed Territory.
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Joint Global Study means a global Clinical Trial or a set of global Clinical Trials of a Licensed Product which include Clinical Trial sites in and outside of the Territory.
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Examples of Joint Global Study in a sentence

  • The Joint Global Development Plan and each Joint Global Study shall be approved by the CC.

  • These sub-questions set out to, firstly, explore the driving forces behind HE change and, secondly, how this change is impacting, not only on the core role and functions of the academic and the degree of academic freedom traditionally associated with this role, but also the scope of academics‟ involvement in institutional decision-making.

  • Any key meetings with a Regulatory Agency regarding a Regulatory Filing with respect to a Joint Global Study shall be conducted by the Sponsor Party for its Sponsored Territory, with prior written notification to the other Party when practicable such that the other Party will have the opportunity to be present with one (1) representative as an observer.

  • Each Joint Global Study Budget, actuals must be reviewed and approved by the CC.

  • For each Joint Global Study under the Joint Development Plan, Arrivent and Allist will review the expense categories in the budget, and actuals, (“Shared Costs”) which means the costs directly attributable or reasonably allocable by each Party for the conduct of each Joint Global Study (including but not limited to CRO, investigators, clinical trial sites, subcontractors) and agree on the Collaborative Cost Model to calculate such Shared Costs.

  • For clarity, nothing in this Collaboration Agreement will be construed as limiting either Party’s right to develop Licensed Product as set forth in the License Agreement outside the scope of the Joint Global Development Plan and this Collaboration Agreement, or as requiring either Party to participate in any Joint Global Study under the Joint Global Development Plan.

  • The sufficiency strategy identifies that there are too many children placed in residential care, work is underway to address this.

  • The Project Team will be responsible for the preparation of the budget, actuals required to conduct each Joint Global Study under the Joint Global Development Plan.

  • Through this intervention, the number of eligible female candidates entering the teaching profession will be increased.

  • Ownership of Inventions and confidentiality and non-use obligations in connection with each Joint Global Study shall be subject to the terms and conditions of the License Agreement.


More Definitions of Joint Global Study

Joint Global Study means a Global Study which includes clinical sites in the Territory and is designed to be sufficient to support Regulatory Approval in Greater China, for which Licensee elects to participate pursuant to Section 4.01(c) and is responsible for paying a portion of costs as set forth in Section 4.02(b).
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Joint Global Study. BioInvent shall, and shall cause its Third Party licensees or sublicensees (as applicable) to, allow CASI to participate in a Joint Global Study by allowing CASI to (i) include and coordinate Clinical Trial sites in the Territory, and (ii) enroll study subjects in the Territory in such Joint Global Study prior to the completion of such Joint Global Study, at an amount to be agreed by Parties, but in any event no less than the minimum amount required by the applicable Regulatory Authorities in the Territory for CASI to qualify the Clinical Trials to be conducted in the Territory as part of the Joint Global Study (along with any data generated by the Joint Global Study outside the Territory) as a Pivotal Trial in the Territory. The Parties shall negotiate in good faith and agree on the details and logistics of any such Joint Global Study. CASI shall be responsible for [***] Development in the Territory by CASI under a Joint Global Study.
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Joint Global Study means a Global Study where a Licensee Entity is the Local Registration Agent in the Territory and for which Licensee is responsible for paying a portion of costs as set forth in Section 8.03(b).
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Related to Joint Global Study

  • Joint Research Committee or “JRC” has the meaning set forth in Section 3.1.1.

  • JDC has the meaning set forth in Section 3.2.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • JSC has the meaning set forth in Section 3.1.

  • Joint Patent Committee or “JPC” has the meaning set forth in Section 7.1.3(a).

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • JRC has the meaning set forth in Section 2.1.1.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • JCC has the meaning set forth in Section 2.1.

  • JPC means Joint Planning Committee.

  • Development Committee has the meaning set forth in Article 3 of the Amended and Restated Research and Development Agreement.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Joint Steering Committee or “JSC” has the meaning set forth in Section 3.1.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • Pivotal Trial means a controlled pivotal clinical trial of Licensed Technology that is prospectively designed to demonstrate statistically whether such Licensed Technology is effective and safe for use in a particular indication in a manner sufficient to obtain regulatory approval to market such product in the United States, European Union, or other foreign jurisdiction.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Development Plan has the meaning set forth in Section 3.2.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.